BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBOND SELF ETCH

    MDR report key: 3447128 · Received September 17, 2013

    Report

    Report Number
    9610902-2013-00098
    Event Type
    Injury
    Date Received
    September 17, 2013
    Manufacturer
    HERAEUS KULZER GMBH & CO. KG, MEDICAL DIVISION
    Product Code
    KLE
    PMA / PMN Number
    K123278
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. THE USER FAILED TO USE THE MATERIAL AS SPECIFIED IN THE DIRECTIONS FOR USE. DUE TO THE AFOREMENTIONED REASON, CAPA MEASURES ARE NOT RECOMMENDED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468771 IBOND SELF ETCH KLE AGENT, TOOTH BONDING, RESIN KLE HERAEUS KULZER GMBH & CO. KG, MEDICAL DIVISION 01

    Patients

    Seq Age Sex Outcome Treatment
    1